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EC number: 212-377-0 | CAS number: 811-97-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- - Only 6 animals (all male) used per dose level. Animals observed for 7 days following exposure.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Norflurane
- EC Number:
- 212-377-0
- EC Name:
- Norflurane
- Cas Number:
- 811-97-2
- Molecular formula:
- C2H2F4
- IUPAC Name:
- 1,1,1,2-tetrafluoroethane
- Details on test material:
- Lot/batch No. Haskell No. 12449; Other codes OCNB-173-180-1
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: ChR-CD
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: 8 weeks
- Weight at study initiation: 250 - 275g
- Fasting period before study: none
- Housing: 2/cage for 7 day pre-test period in 8" x 8" x 14" steel cages
- Diet (e.g. ad libitum): food (Purina® Laboratory Chow) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7days
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: glass exposure chamber
- Exposure chamber volume: 20 litres
- Method of holding animals in test chamber: not specified
- Source and rate of air: Houseline air supplemented with oxygen diluted the vapour stream prior to entering the chamber
- Method of conditioning air: not specified
TEST ATMOSPHERE
- Brief description of analytical method used: Gas standards and samples were analysed using a Varian Gas Chromatograph (Model 600D) equipped with a Hydrogen Generator (Model 650) and a flame ionization detector. Nitrogen, the carrier gas, flowed through the 1' x 1/8" O.D. stainless steel column packed with 10% SE 30 on Chromosorb WHP of 80/100 mesh. The column was operated isothermically at 50°C. Automatic sampling of chamber atmosphere was done at 30 minute intervals. Gas standards were prepared by injecting measured amounts of pure HFC 134a into glass gas bottles under vacuum.; bottles were vented allowing mixture of room air and HFC 134a.
- Samples taken from breathing zone: yes
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- Time weighted average concentration ppm (range): 81100 (73800-84100); 205200 (180100-226000); 359300 (327000-378200); 566700 (494400-668800); 646700 (623800-664300); 652700 (581600-685300)
- No. of animals per sex per dose:
- 6 males
- Control animals:
- no
- Details on study design:
- Groups of 6 ChR-CD® rats were exposed by whole body method to atmospheres composed of HFC 134a and air supplemented with oxygen for single 4 hour tests. Following exposures surviving rats were returned to their respective cages for food and water available ad libitum. The rats were kept under observation during exposure, as well as for 7 days before and after each test.
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LCLo
- Effect level:
- >= 567 000 ppm
- Exp. duration:
- 4 h
- Mortality:
- Mortalities were 0/6 at 81,100, 205,200 and 359,300 ppm (338,000, 855,000, 1,497,900 mg/m3), 5/6 at 566,700 ppm (2,362,600 mg/m3), 0/6 at 646,700 ppm (2,696,100 mg/m3) and 2/6 at 652,700 ppm (2,721,100 mg/m3).
- Clinical signs:
- other: Clinical signs reported during the exposure included lethargy, laboured and rapid respiration, salivation and tearing.
- Body weight:
- 359300ppm: 4/6 lost 3 - 9 g within 24 hours of exposure, followed by weight gain
652700ppm: 4/4 survivors lost 7 - 32g within 24 hours of exposure, followed by weight gain.
Any other information on results incl. tables
Time-weighted averageConcentration of HFC 134a ppm (range) | Mortalities: No. rats dead/ No. of rats tested | Observations |
81100 (73800 - 84100) | 0/6 | Exposure: No Abnormalities Detected (NAD) Recovery: NAD |
205200 (180100 - 226000) | 0/6 | Exposure: lethargy, rapid respiration Recovery: NAD |
359300 (327000 - 378000) | 0/6 | Exposure: lethargy, rapid respiration, trembling, tearing Recovery: 4/6 lost 3 -9g within 24 hours of exposure, followed by weight gain |
566700 (494400 - 668800) | 5/6* | Exposure: 5 fatalities; laboured rapid respiration, foaming at the nose, pallorRecovery: * data unavailable for the recovery phase |
646700 (623800 - 664300) | 0/6 | Exposure: lethargy, rapid respiration, trembling, tearing Recovery: NAD |
652700 (581600 - 685300) | 2/6 | Exposure: 2 fatalities; laboured rapid respiration, foaming at the nose, tearing Recovery: 4/4 lost from 7 -32g within 24 hours of exposure, followed by weight gain |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Groups of 6 male albino ChR-CD® rats were exposed to various concentrations of 1,1,1,2-tetrafluoroethane for 4 hours. The lowest concentration that produced death was 567000 ppm (range of 494000 to 669000 ppm). Clinical signs of toxicity included lethargy, laboured and rapid respiration, foaming at the nose, tearing, salivation, pallor and weight loss.
- Executive summary:
An approximate 4-hour lethal concentration (ALC), the lowest concentration that produced death, of 567,000 ppm HFC-134a (2,360,000 mg/m3) in the male ChR-CD rat (6/group) has been reported. In this study, mortalities were 0/6 at 81,100, 205,200 and 359,300 ppm (338,000, 855,000, 1,497,900 mg/m3), 5/6 at 566,700 ppm (2,362,600 mg/m3), 0/6 at 646,700 ppm (2,696,100 mg/m3) and 2/6 at 652,700 ppm (2,721,100 mg/m3). The range of measured concentrations in the 566,700 ppm group at which high mortality occurred was very wide, 494,400 to 668,800 ppm (2,061,200 ‑ 2,788,200 mg/m3), the highest concentration exceeding that of the second highest group 664,300 ppm (2,769,500 mg/m3) and similar to the high end of the range for the highest concentration group at 685,300 ppm (2,857,000 mg/m3). Clinical signs reported during the exposure included lethargy, laboured and rapid respiration, salivation and tearing.
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